The purpose of this study is to evaluate the objective response rate of a combination of letrozole (Femara) and bevacizumab (Avastin) given preoperatively to postmenopausal patients with hormone sensitive breast cancer.

To correlate response with biological correlates detected at baseline and after 1 cycle of treatment with either bevacizumab alone or bevacizumab combined with letrozole [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

To assess the tolerability of 14 weeks of neoadjuvant letrozole combined with bevacizumab [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Postmenopausal defined as Age ≥ 60 years and/or Age >45 years with amenorrhea 12 months with an intact uterus and/or History of bilateral oophorectomy and/or FSH and estradiol levels in postmenopausal range

Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial

Use of effective means of contraception (men and women) in subjects of child-bearing potential

Exclusion Criteria:

Prior history of and/or therapy for invasive breast cancer (includes chemotherapy, radiation, hormonal therapy including AIs, tamoxifen, raloxifene, fulvestrant or any other antiestrogen/SERM)

Clinically significant cardiovascular disease, EF <50%

Known CNS disease

History of deep vein thrombosis or pulmonary embolism

Proteinuria at screening as demonstrated by either Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening OR Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).

Presence of non-healing wound or fracture

Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study

Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0

Core biopsy or other minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0

Pregnant (positive pregnancy test) or lactating. Use of effective means of contraception (men and women) in subjects of child-bearing potential is mandatory

History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0

Known hypersensitivity to any component of bevacizumab or letrozole

Inability to comply with study and/or follow-up procedures

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461773

Locations

United States, Connecticut

Yale University, Yale Cancer Center

New Haven, Connecticut, United States, 06520

Sponsors and Collaborators

Yale University

Novartis

Genentech, Inc.

Investigators

Principal Investigator:

Gina Chung, M.D.

Yale University

More Information

Responsible Party:

Gina Chung, M.D., Principal Investigator, Yale University School of Medicine